Evidence map›Paper›PMID 39814420›Full record

Trial reportBMJ (Clinical research ed.)2025

The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial.

Jianfeng Wu, Fei Pei, Lixin Zhou, Weiqin Li, Renhua Sun, Yimin Li, Zheng Wang, Zhijie He, Xiaofei Zhang, Xiaodong Jin and 23 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02867267 (The Efficacy and Safety of Thymosin Alpha 1 for Sepsis), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02867267 phase3completednot on this map

The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2016 to 2021Enrolled1,106ConditionsSepsisArmsThymosin alpha 1, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  4. [Pharmacological immunomodulation in sepsis].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors.

Jianfeng WuDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China.
Fei PeiDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China.
Lixin ZhouDepartment of Critical Care Medicine, The First People's Hospital of Foshan, Foshan, Guangdong province, China.
Weiqin LiDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu province, China.
Renhua SunEmergency and Critical Care Center, Intensive Care Unit, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), Hangzhou, Zhejiang province, China guanxd@mail.sysu.edu.cn.
Yimin LiDepartment of Critical Care Medicine, State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, China.
Zheng WangDepartment of Hepatobiliary Surgery, Department of Surgical Intensive Care Unit, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi province, China.
Zhijie HeDepartment of Critical Care Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong province, China.
Xiaofei ZhangDepartment of Intensive Care Unit, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China.
Xiaodong JinDepartment of Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China.
Yun LongDepartment of Critical Care Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Wei CuiDepartment of Critical Care Medicine, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang province, China.
Chunting WangDepartment of Critical Care Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong province, China.
Erzhen ChenDepartment of Emergency, Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.
Jun ZengDepartment of Critical Care Medicine, Guangzhou First People's Hospital, Guangzhou, Guangdong province, China.
Jing YanDepartment of Intensive Care, Zhejiang Hospital, Hangzhou, Zhejiang province, China.
Qinhan LinDepartment of Critical Care Medicine, Affiliated Qingyuan Hospital, The Sixth Clinical Medical School, Guangzhou Medical University, Qingyuan People's Hospital, Qingyuan, Guangdong Province, China.
Feihu ZhouDepartment of Critical Care Medicine, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.
Lei HuangDepartment of Critical Care Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong Province, China.
You ShangDepartment of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei province, China.
Meili DuanDepartment of Critical Care Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Wei ZhengDepartment of Critical Care Medicine, Zhuhai People's Hospital, Zhuhai, Guangdong Province, China.
Duming ZhuDepartment of Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.
Qiuye KouDepartment of Intensive Care Unit, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China.
Shihong ZhangDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China.
Yin LiuDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China.
Chen YaoPeking University First Hospital, Beijing, China.
Meixia ShangPeking University First Hospital, Beijing, China.
Sui PengClinical Trials Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.
Qian ZhouClinical Trials Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.
Kar Keung ChengDepartment of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK.
Xiangdong GuanDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China guanxd@mail.sysu.edu.cn.ORCID 0000-0002-5050-0359
TESTS study collaborator group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether the immunomodulatory drug thymosin α1 reduces mortality in adults with sepsis.

designMulticentre, double blinded, placebo controlled phase 3 trial.

setting22 centres in China, September 2016 to December 2020.

participants1106 adults aged 18-85 years with a diagnosis of sepsis according to sepsis-3 criteria and randomly assigned in a 1:1 ratio to receive thymosin α1 (n=552) or placebo (n=554). A stratified block method was used for randomisation, and participants were stratified by age (<60 and ≥60 years) and centre.

interventionsSubcutaneous injection of thymosin α1 or placebo every 12 hours for seven days unless discontinued owing to discharge from the intensive care unit, death, or withdrawal of consent.

main outcome measureThe primary outcome was 28 day all cause mortality after randomisation. All analyses were based on a modified intention-to-treat set, including participants who received at least one dose of study drug.

resultsOf 1106 adults with sepsis enrolled in the study, 1089 were included in the modified intention-to-treat analyses (thymosin α1 group n=542, placebo group n=547). 28 day all cause mortality occurred in 127 participants (23.4%) in the thymosin α1 group and 132 (24.1%) in the placebo group (hazard ratio 0.99, 95% confidence interval 0.77 to 1.27; P=0.93 with log-rank test). No secondary or safety outcome differed statistically significantly between the two groups. The prespecified subgroup analysis showed a potential differential effect of thymosin α1 on the primary outcome based on age (<60 years: hazard ratio 1.67, 1.04 to 2.67; ≥60 years: 0.81, 0.61 to 1.09; P for interaction=0.01) and diabetes (diabetes: 0.58, 0.35 to 0.99; no diabetes: 1.16, 0.87 to 1.53; P for interaction=0.04).

conclusionsThis trial found no clear evidence to suggest that thymosin α1 decreases 28 day all cause mortality in adults with sepsis.

trial registrationClinicalTrials.gov NCT02867267.

Indexed as

SepsisThymalfasinThymosinAdolescentAdultAgedAged, 80 and overChinaDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomeYoung AdultThymalfasinThymosin

Identifiers

PMID39814420
PMCPMC11780596

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.